Results 91 to 100 of about 16,124 (183)

From In Vivo Predictive Dissolution to Virtual Bioequivalence: A GastroPlus^®-Driven Framework for Generic Candesartan Cilexetil Tablets

Pharmaceuticals
Background: Candesartan cilexetil, a Biopharmaceutics Classification System (BCS) II prodrug, demonstrates compromised bioavailability attributable to its limited aqueous solubility coupled with P-glycoprotein (P-gp)-mediated efflux and hepatic first ...
Hao Ruan, Xiaoting Geng, Zijing Situ, Qian Shen, Tianjian Ye, Xin Chen, Weike Su   +6 more
doaj   +1 more source

Comparison of tape stripping with the human skin blanching assay for the bioequivalence assessment of topical clobetasol propionate formulations.

Journal of Pharmacy & Pharmaceutical Sciences, 2010
Purpose: A draft guidance on tape stripping for assessing the bioavailability/bioequivalence of topical formulations was issued by the United States Food and Drug Administration in 1998 but has since been withdrawn.
Wai Ling Au, Michael F Skinner, Isadore Kanfer   +2 more
doaj   +1 more source

Planning and evaluation of bioequivalence studies of rosuvastatin drug products

Регуляторные исследования и экспертиза лекарственных средств, 2018
The article reviews bioequivalence studies of Russian and foreign generic rosuvastatin preparations with the goal of harmonizing approaches to rosuvastatin bioequivalence studies in the Russian Federation.
D. P. Romodanovsky, D. V. Goryachev
doaj  

Generic versus branded imatinib in frontline chronic myeloid leukemia: A systematic review and meta‐analysis

HemaSphere, Volume 10, Issue 10, October 2026.
Shankar Biswas, Yashasvi Srivastava, Nayanika Tummala, Ayman Hamadttu   +3 more
wiley   +1 more source

Update on the advances and challenges in bioequivalence testing methods for complex topical generic products

Frontiers in Pharmacology
Most of the government regulatory agencies, including the United States Food and Drug Administration and the European Medicine Agency, demand that the generic complex topical products prove pharmaceutical and bioequivalence.
Nedaa Alomari, Waleed Alhussaini
doaj   +1 more source

Bioequivalence study of two formulations of candesartan cilexetil tablet in healthy subjects under fasting conditions

, 2013
Raymond R Tjandrawinata,1 Effi Setiawati,2 Danang Agung Yunaidi,2 Ronal Simanjuntak,2 Iwan Dwi Santoso,2 Liana W Susanto1 1Dexa Laboratories of Biomolecular Sciences (DLBS), Cikarang, Indonesia; 2Bioavailability and Bioequivalence Laboratory, PT Equilab ...
Tjandrawinata RR, Yunaidi DA, Susanto LW, Santoso ID, Setiawati E, Simanjuntak R   +5 more
core  

Can 3D Printed Tablets Be Bioequivalent and How to Test It: A PBPK Model Based Virtual Bioequivalence Study for Ropinirole Modified Release Tablets

Pharmaceutics
As the field of personalized dosing develops, the pharmaceutical manufacturing industry needs to offer flexibility in terms of tailoring the drug release and strength to the individual patient’s needs.
Olha Shuklinova, Gabriela Wyszogrodzka-Gaweł, Ewelina Baran, Bartosz Lisowski, Barbara Wiśniowska, Przemysław Dorożyński, Piotr Kulinowski, Sebastian Polak   +7 more
doaj   +1 more source

Bioequivalence Study of Two Formulations Containing Irbesartan 300 Mg Tablets in Healthy Colombian Volunteers

, 2015
5 páginasThis is a pharmacokinetic study of two formulations containing Irbesartan 300 mg. Its objective was to compare the Bioavailability between the Test product (Irbesartan produced by Tecnoquímicas S.A., Colombia laboratory) and the Reference ...
Bustamante C., Villarraga EA., Vargas M.
core   +1 more source

Production of Functional Trastuzumab in Phaeodactylum tricornutum: Advancing Microalgae as Next‐Generation Sustainable Antibody Biofactories

Plant Biotechnology Journal, Volume 24, Issue 10, Page 5405-5407, October 2026.
Charlotte Toustou, Manon Salvetti, Magalie Bénard, Christelle Fécourt, Sébastien Calbo, Kylian Jouie, France Blanchard, Camille N'Zué, Chloé Placines, Thomas Badou, Nicolas Piton, Patrice Lerouge, Ludovic Galas, Muriel Bardor   +13 more
wiley   +1 more source

Formulation and bioequivalence studies of choline alfoscerate tablet comparing with soft gelatin capsule in healthy male volunteers

, 2019
Mi-Hong Min,1,2 Jin-Hyong Park,2 Jong-Hyun Hur,2 Ho-Chul Shin,2 YoungJoo Cho,2 Dae-Duk Kim11College of Pharmacy and Research Institute of Pharmaceutical Sciences, Seoul National University, Seoul 08826, Republic of Korea; 2Central Research Institute ...
Park JH, Kim DD, Min MH, Shin HC, Cho YJ, Hur JH   +5 more
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